Attached files
file | filename |
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8-K - PDL BIOPHARMA, INC. | v204328_8k.htm |
EX-99.3 - PDL BIOPHARMA, INC. | v204328_ex99-3.htm |
EX-99.2 - PDL BIOPHARMA, INC. | v204328_ex99-2.htm |
Contacts:
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|
Cris
Larson
|
Jennifer
Williams
|
PDL
BioPharma, Inc.
|
Cook
Williams Communications, Inc.
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775-832-8505
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360-668-3701
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Cris.Larson@pdl.com
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jennifer@cwcomm.org
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PDL
BioPharma Provides Fourth Quarter 2010 Revenue Guidance of $74
Million
INCLINE
VILLAGE, NV, December 1, 2010
– PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today announced revenue
guidance for the fourth quarter ending December 31, 2010 of approximately $74
million, as compared with actual results of $58.3 million for the fourth quarter
of 2009, a 27 percent year-over-year increase. The growth is
primarily driven by increased third quarter 2010 sales of Avastin®,
Herceptin®,
Lucentis® and
Tysabri® for
which PDL receives royalties in the fourth quarter of 2010. The
royalty payment received from Genentech included royalties generated on all
worldwide sales.
Sales of
Avastin, Herceptin and Lucentis are subject to a tiered royalty rate for product
that is made or sold in the United States and a flat royalty rate of three
percent for product that is manufactured and sold outside of the United
States. The net sales thresholds and the applicable royalty rates for
product that is made or sold in the United States are outlined below:
Royalty Rate
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||
Net
sales up to $1.5 billion
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3.0%
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Net
sales between $1.5 billion and $2.5 billion
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2.5%
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Net
sales between $2.5 billion and $4.0 billion
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2.0%
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Net
sales exceeding $4.0 billion
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1.0%
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Reported
sales for Avastin increased 8.7 percent in the third quarter of 2010 when
compared to the same period in 2009. Roche recently reported that global sales
of Avastin for advanced colorectal, breast, lung and kidney cancer, and for
relapsed glioblastoma, rose 11 percent in the first nine months of 2010 driven
by strong positive uptake of the product overall. Roche also reported
that slower U.S. sales, especially in the third quarter, reflected regulatory
and reimbursement uncertainty regarding the metastatic breast cancer
indication. Contributing to increased Avastin royalties were sales of
Avastin that was both manufactured and sold outside the United
States. Ex-U.S. manufactured and sold Avastin sales represented 26
percent of total Avastin sales; there were no sales of ex-U.S. manufactured and
sold Avastin prior to the fourth quarter of 2009.
Reported
sales for Herceptin increased 10.2 percent in the third quarter of 2010 when
compared to the same period in 2009. Roche recently announced that
global sales of Herceptin for HER2-postive breast cancer and advanced stomach
cancer increased eight percent in the first nine months of 2010 driven by
further penetration in the early and metastatic breast cancer settings,
particularly in emerging markets. Additionally, Roche reported that
sales continue to benefit from uptake in advanced HER2-positive stomach cancer
in Europe and other markets. Also contributing to increased Herceptin
royalties were sales of Herceptin that was both manufactured and sold outside
the United States. Ex-U.S. manufactured and sold Herceptin sales
represented 40 percent of total Herceptin sales in the third quarter of 2010 as
compared with 22 percent in the third quarter of 2009.
Reported
sales for Lucentis increased 30.8 percent in the third quarter of 2010 when
compared to the same period in 2009. Lucentis is approved for the
treatment of age-related macular degeneration in the United States and in Europe
and received approval for the treatment of macular edema following retinal vein
occlusion in June 2010 in the United States. Roche and Novartis
recently reported that sales grew by 29 percent and 30 percent for the first
nine months of 2010 in the United States and internationally,
respectively.
Reported
sales for Tysabri increased 10.9 percent in the third quarter of 2010 when
compared to the same period in 2009. Biogen Idec recently announced
that at the end of September 2010, approximately 55,100 patients were on therapy
worldwide representing an increase of 19 percent over the approximately 46,200
patients who were on therapy at the end of September 2009. Tysabri
royalties are determined at a flat rate as a percent of sales regardless of
location of manufacture or sale.
The sales
information presented above is based on information provided by PDL’s licensees
in their quarterly reports to the Company as well as from public disclosures
made by PDL’s licensees.
About
PDL BioPharma
PDL
pioneered the humanization of monoclonal antibodies and, by doing so, enabled
the discovery of a new generation of targeted treatments for cancer and
immunologic diseases. PDL is focused on maximizing the value of its antibody
humanization patents and related assets. The Company receives royalties on sales
of a number of humanized antibody products marketed by leading pharmaceutical
and biotechnology companies today based on patents which expire in late 2014.
For more information, please visit www.pdl.com.
NOTE: PDL
BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma,
Inc.
Forward-looking
Statements
This
press release contains forward-looking statements. Each of these forward-looking
statements involves risks and uncertainties. Actual results may differ
materially from those, express or implied, in these forward-looking statements.
Factors that may cause differences between current expectations and actual
results include, but are not limited to, the following:
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·
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The
expected rate of growth in royalty-bearing product sales by PDL’s existing
licensees;
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·
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The
relative mix of royalty-bearing Genentech products manufactured and sold
outside the U.S. versus made or sold in the
U.S.;
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|
·
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The
ability of our licensees to receive regulatory approvals to market and
launch new royalty-bearing products and whether such products, if
launched, will be commercially
successful;
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|
·
|
Changes
in any of the other assumptions on which PDL’s projected royalty revenues
are based;
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·
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The
outcome of pending litigation or
disputes;
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|
·
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The
change in foreign currency exchange rate;
and
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·
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The
failure of licensees to comply with existing license agreements, including
any failure to pay royalties due.
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Other
factors that may cause PDL's actual results to differ materially from those
expressed or implied in the forward-looking statements in this press release are
discussed in PDL's filings with the SEC, including the "Risk Factors" sections
of its annual and quarterly reports filed with the SEC. Copies of PDL's filings
with the SEC may be obtained at the "Investors" section of PDL's website at
www.pdl.com. PDL expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements contained
herein to reflect any change in PDL's expectations with regard thereto or any
change in events, conditions or circumstances on which any such statements are
based for any reason, except as required by law, even as new information becomes
available or other events occur in the future. All forward-looking statements in
this press release are qualified in their entirety by this cautionary
statement.